Real-world data on the effectiveness of TYRX and TauroPace for preventing CIED infections.

IF 1.3 American journal of cardiovascular disease Pub Date : 2024-08-25 eCollection Date: 2024-01-01 DOI:10.62347/DSHG1684
Andrea Messori, Maria Rita Romeo, Melania Rivano, Sabrina Trippoli
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Abstract

Background: The implantation of cardiac implantable electronic devices (CIEDs) carries a known risk of infection. Two devices (TYRX and TauroPace) have been proposed to reduce this risk.

Methods: The aim of our study was to compare the effectiveness of TauroPace and TYRX. Real-world comparative studies were included. Data analysis was based on reconstruction of individual patient data from Kaplan-Meier curves using an artificial intelligence algorithm. The endpoint was CIED infection or systemic infection. Statistical tests included heterogeneity assessment, superiority testing, and non-inferiority testing. The primary outcome measure was the hazard ratio (HR) with confidence interval (CI).

Results: Our literature search identified two real-world studies suitable for our analysis. Follow-up was 12 months for TauroPace (654 patients) and 60 months for TYRX (872 patients), with a total of 2,083 controls. There was no heterogeneity among controls. Compared to the pooled control group, patients treated with TYRX or TauroPace had fewer CIED infections (HR, 0.3892; 95% CI, 0.2042-0.7419; P=0.00414; HR, 0.3313; 95% CI, 0.1005-1.0925; P=0.06958, respectively). When testing for non-inferiority of TauroPace vs. TYRX, the comparison yielded a HR of 0.8494 (in favor of TYRX) with a 90% CI of 0.27-2.63; this CI of TauroPace did not meet the non-inferiority criterion set at HR>0.75 (i.e., relative difference ≤25%).

Conclusions: Both treatments had some important drawbacks. Regarding TYRX, more selective use in higher-risk patients should be advocated to improve its cost-effectiveness, but robust evidence is still lacking. Regarding TauroPace, our analysis testing for a non-inferiority margin of ≤25% did not meet this demonstration.

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关于 TYRX 和 TauroPace 预防 CIED 感染有效性的真实世界数据。
背景:植入心脏植入式电子设备(CIEDs)具有已知的感染风险。有两种设备(TYRX 和 TauroPace)被建议用于降低这一风险:我们的研究旨在比较 TauroPace 和 TYRX 的有效性。研究纳入了真实世界的比较研究。数据分析基于使用人工智能算法从 Kaplan-Meier 曲线重建的单个患者数据。终点为CIED感染或全身感染。统计检验包括异质性评估、优越性检验和非劣性检验。主要结果测量指标为危险比(HR)和置信区间(CI):我们的文献检索发现了两项适合我们分析的真实世界研究。TauroPace的随访时间为12个月(654名患者),TYRX的随访时间为60个月(872名患者),共有2083名对照组患者。对照组之间不存在异质性。与汇总对照组相比,接受TYRX或TauroPace治疗的患者CIED感染率较低(HR,0.3892;95% CI,0.2042-0.7419;P=0.00414;HR,0.3313;95% CI,0.1005-1.0925;P=0.06958)。在检测TauroPace与TYRX的非劣效性时,比较得出的HR为0.8494(TYRX更优),90% CI为0.27-2.63;TauroPace的这一CI不符合HR>0.75的非劣效性标准(即相对差异≤25%):结论:两种疗法都存在一些重要缺陷。关于TYRX,应提倡在高风险患者中更有选择性地使用,以提高其成本效益,但目前仍缺乏有力的证据。至于 TauroPace,我们的分析测试非劣效边际≤25%,但并未达到这一指标。
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来源期刊
American journal of cardiovascular disease
American journal of cardiovascular disease CARDIAC & CARDIOVASCULAR SYSTEMS-
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发文量
21
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